Somatropin Uses

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• Somatropin indications
• Uses of Somatropin in details
• Somatropin description
• Somatropin dosage
• Somatropin interactions
• Somatropin side effects
• Somatropin contraindications

What is Somatropin?

Somatropin (Somatropin) is a form of human growth hormone important for the growth of bones and muscles. It is similar to the growth hormone your body manufactures.

Somatropin is used to treat Short Bowel Syndrome (SBS) in patients who are on a specialized diet.

When used with along with special diet, Somatropin helps your bowel take in more water, electrolytes and nutrients and lowers the need for I.V. (intravenous) feedings.

Somatropin is not cure for Short Bowel Syndrome.

Somatropin indications

Pediatric Patients

Somatropin [Somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH).

Somatropin [Somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome.

Somatropin [Somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with short stature associated with Turner syndrome.

Somatropin [Somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years.

Adult Patients

Somatropin [Somatropin (rDNA origin) injection] is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

• Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
• Childhood Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with Somatropin for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of Somatropin therapy at the reduced dose level recommended for GHD adults. According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

How should I use Somatropin?

Use Somatropin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Somatropin. Talk to your pharmacist if you have questions about this information.
• Somatropin is given as an injection. A health care provider will teach you how to use it. Be sure you understand how to use Somatropin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Allow Somatropin to come to room temperature before you use it.
• Check the injection device to be sure the correct dose is dialed before you use a dose of Somatropin.
• Wash your hands before and immediately after using Somatropin.
• Use a new needle each time you inject Somatropin. Do not reuse needles.
• Do not use Somatropin if it contains particles, is cloudy or discolored, or if the pen or cartridge is cracked or damaged.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
• Always rotate injection sites each time you use Somatropin.
• Do not shake Somatropin. Swirl gently to mix it.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Somatropin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Somatropin.

Uses of Somatropin in details

Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting.

Somatropin is also used to increase height in children with certain genetic disorders (such as Noonan syndrome, Turner's syndrome).

How to use Somatropin subcutaneous

Read the Patient Information Leaflet that may come with your brand of this medication provided by your pharmacist before you start using Somatropin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Some brands of this medication are given by injection into a muscle or under the skin. Some brands may only be injected under the skin. The way you inject this medicine will depend on the brand that you are using. Check with your pharmacist to ensure that the way you are injecting your medicine is correct. It is important to change the location of the injection site to avoid problem areas under the skin. For best results, this medication must be used exactly as prescribed by your doctor. It is important to understand your therapy and to follow your doctor's instructions closely.

The dosage is based on your age, weight, medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake while mixing the solution. Shaking makes the medication not work properly. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

If this medicine is used for short bowel syndrome, consult your doctor if a special diet (high carbohydrate/low-fat) or the use of nutritional supplements may be helpful.

If this medicine is used for weight loss/muscle wasting, it may take up to 2 weeks to notice the effects of the drug. Do not use more of this medication than prescribed or use it more often since the risk of side effects will be increased.

Somatropin description

Each cartridge contains Somatropin (recombinant human growth hormone) 5.83 mg/mL (6 mg/1.03 mL) and 8 mg/mL (12 mg/1.5 mL), respectively. It also contains the following excipients: Sucrose, poloxamer 188, phenol, citric acid and citrate buffer.

Each vial of Somatropin 3.33 mg contains Somatropin (recombinant human growth hormone) accompanied by a vial of diluent containing saline 5 mL with benzyl alcohol (0.9% w/v sodium chloride and 0.9% w/v benzyl alcohol).

Each click.easy vial contain Somatropin (recombinant human growth hormone). Somatropin is produced by recombinant deoxyribonucleic acid technology in mammalian cells.

Reconstitution with the content of the bacteriostatic solvent cartridge gives a concentration of 5.83 mg/mL.

Somatropin 6-mg and 8-mg is clear to slightly opalescent solution with pH of 5.6-6.6 and osmolality 250-450 mOsm/kg.

Somatropin dosage

The Somatropin (Somatropin (rdna origin) for inj) dosage and administration schedule should be individualized for each patient. Response to GH therapy in pediatric patients tends to decrease over time. However in pediatric patients, failure to increase growth rate, particularly during the first year of therapy, suggests the need for close assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, undernutrition, and advanced bone age.

Once-Monthly Injection - It is recommended that an SC injection at a dosage of 1.5 mg/kg body weight be administered on the same day of each month. Dosages above the recommended once-monthly regimen have not been studied in clinical trials. Note: subjects over 15 kg will require more than one injection per dose.

Twice-Monthly Injections - It is recommended that an SC injection at a dosage of 0.75 mg/kg body weight be administered twice each month on the same days of each month (e.g., Days 1 and 15 of each month). Dosages above the recommended twice-monthly regimen have not been studied in clinical trials. Note: subjects over 30 kg will require more than one injection per dose.

The table below indicates the required number of injections per dose.

Preparation of Dose

Somatropin (Somatropin (rdna origin) for inj) powder may only be suspended in Diluent for Somatropin supplied in the kit and administered with the supplied needles.

1. Using the chart below, determine the volume of diluent needed to suspend Somatropin (Somatropin (rdna origin) for inj). Withdraw the diluent into a 3 cc syringe using the needle supplied in the kit. Only the diluent supplied in the kit should be used for reconstitution, and any remaining diluent should be discarded.

Note: Since the suspension is viscous and prevents complete withdrawal of the entire vial contents, the vials are overfilled to ensure delivery of the labeled amount of Somatropin. Using these diluent volumes for final suspension results in a final concentration of 19 mg/mL Somatropin in each vial size.

2. Inject the diluent into the vial against the vial wall. Swirl the vial vigorously for up to 2 minutes to disperse the powder in the diluent. Mixing is complete when the suspension appears uniform, thick, and milky, and all the powder is fully dispersed. Do not store the vial after reconstitution or the suspension may settle.

3. Withdraw the required dose. Only one vial should be used for each injection. Replace the needle with a new needle from the kit and administer the dose immediately to avoid settling of the suspension in the syringe. Deliver the dose from the syringe at a continuous rate over not more than 5 seconds. Discard unused vial contents as the product contains no preservative. An extra needle has been provided in the kit.

Stability and Storage

Before Suspension - Somatropin (Somatropin (rdna origin) for inj) and diluent vials must be stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing the vials of Somatropin (Somatropin (rdna origin) for inj) and Diluent for Somatropin (Somatropin (rdna origin) for inj). Do not expose the Somatropin (Somatropin (rdna origin) for inj) vial to temperatures above 25°C (77°F). Expiration dates are stated on the labels.

After Suspension - Because Somatropin (Somatropin (rdna origin) for inj) contains no preservatives, all injections must be given immediately. Do not allow the suspension to settle prior to withdrawal of the dose. Suspended solution cannot be stored or used to suspend another vial of Somatropin (Somatropin (rdna origin) for inj).

How supplied

Somatropin (Somatropin (rdna origin) for inj) is supplied as single-use vials with 13.5 mg, 18 mg, or 22.5 mg sterile, preservative-free Somatropin powder per vial.

Each 13.5 mg kit contains one single-use 13.5 mg vial of Somatropin® [Somatropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Somatropin (Somatropin (rdna origin) for inj), and three 21-gauge, 1/2" needles: NDC 50242-032-35.

Each 18 mg kit contains one single-use 18 mg vial of Somatropin® [Somatropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Somatropin (Somatropin (rdna origin) for inj), and three 21-gauge, 1/2" needles: NDC 50242-034-41.

Each 22.5 mg kit contains one single-use 22.5 mg vial of Somatropin® [Somatropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Somatropin (Somatropin (rdna origin) for inj), and three 21-gauge, 1/2" needles: NDC 50242-036-54.

Somatropin™ [Somatropin (rDNA origin) for injectable suspension] and Diluent for Somatropin (Somatropin (rdna origin) for inj) are manufactured for: Genentech, Inc. 1 DNA Way, South San Francisco, CA 94080-4990.

Somatropin interactions

See also:
What other drugs will affect Somatropin?

11β-Hydroxysteroid Dehydrogenase Type 1

The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH and Somatropin inhibit 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Introduction of Somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. As a consequence, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required in patients treated with Somatropin. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.

Pharmacologic Glucocorticoid Therapy And Supraphysiologic Glucocorticoid Treatment

Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of Somatropin in children. Therefore, glucocorticoid replacement dosing should be carefully adjusted in children receiving concomitant Somatropin and glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.

Cytochrome P450-Metabolized Drugs

Limited published data indicate that Somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance in man. These data suggest that Somatropin administration may alter the clearance of compounds metabolized by CP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Therefore, careful monitoring is advised when Somatropin is administered in combination with drugs metabolized by CP450 liver enzymes. However, formal drug interaction studies have not been conducted.

Oral Estrogen

Because oral estrogens may reduce the serum IGF-I response to Somatropin treatment, girls and women receiving oral estrogen replacement may require greater Somatropin dosages.

Insulin And/Or Other Hypoglycemic Agents

Patients with diabetes mellitus who receive concomitant treatment with Somatropin may require adjustment of their doses of insulin and/or other hypoglycemic agents.

Drug Abuse And Dependence

Inappropriate use of Somatropin by individuals who do not have indications for which Somatropin is approved, may result in significant negative health consequences. Somatropin is not a drug of dependence.

Somatropin side effects

See also:
What are the possible side effects of Somatropin?

As with all protein pharmaceuticals, patients may develop antibodies to the protein. GH antibody-binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. In clinical studies of pediatric patients who were treated with Somatropin (Somatropin (rdna origin) for inj), 0/138 patients with GHD screened for antibody production developed antibodies with binding capacities ≥ 2 mg/L at any time during a treatment period of up to 17.4 months.

In addition to an evaluation of compliance with the prescribed treatment program and thyroid status, testing for antibodies to GH should be carried out in any patient who fails to respond to therapy.

In studies involving 138 pediatric patients treated with Somatropin (Somatropin (rdna origin) for inj), the most frequent adverse reactions were injection-site reactions, which occurred in nearly all patients. On average, 2 to 3 injection-site adverse reactions were reported per injection. These reactions included nodules (61% of injections), erythema (53%), pain post-injection (47%), pain during injection (43%), bruising (20%), itching (13%), lipoatrophy (13%), and swelling or puffiness (8%). The intensity of these reactions was generally rated mild to moderate, with pain during injection occasionally rated as severe (7%).

Adverse reactions observed less frequently in the Somatropin (Somatropin (rdna origin) for inj) studies which were considered possibly, probably, or definitely related to the drug by the treating physician (usually occurring 1–3 days postdose) included: headache (13% of subjects), nausea (8%), lower extremity pain (7%), fever (7%), and vomiting (5%). These symptoms were generally self-limited and well-tolerated. One patient experienced a generalized body rash that was most likely an allergic reaction to Somatropin (Somatropin (rdna origin) for inj).

Leukemia has been reported in a small number of GHD patients treated with GH. It is uncertain whether this increased risk is related to the pathology of GH deficiency itself, GH therapy, or other associated treatments such as radiation therapy for intracranial tumors. On the basis of current evidence, experts cannot conclude that GH therapy is responsible for these occurrences.

Other adverse drug reactions that have been reported in GH-treated patients include the following: 1) Metabolic: mild, transient peripheral edema; 2) Musculoskeletal: arthralgia, carpal tunnel syndrome; 3) Skin: rare increased growth of pre-existing nevi; patients should be monitored for malignant transformation; 4) Endocrine: gynecomastia; and 5) Rare pancreatitis. Of these reactions, only edema ( < 1% of patients) and arthralgia (4%) were reported as related to drug in the Somatropin (Somatropin (rdna origin) for inj) studies.

Somatropin contraindications

See also:
What is the most important information I should know about Somatropin?

Somatropin should not be used to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure as increased mortality may occur.

Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when Somatropin was used in such patients. Somatropin® is not indicated for the treatment of patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Somatropin should not be used or should be discontinued with any evidence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with Somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Patients with preexisting tumors or GHD secondary to an intracranial lesion should be monitored routinely for progression or recurrence. In childhood cancer survivors, an increased risk of a second neoplasm, particularly meningiomas in patients treated with radiation to the head for their first neoplasm, has been reported in patients treated with Somatropin.

Somatropin should not be used in patients with active proliferative or severe non-proliferative diabetic retinopathy, for growth promotion in pediatric patients with closed epiphyses, or in patients with known hypersensitivity to Somatropin or any of its excipients.

Active ingredient matches for Somatropin:

Somatropin

References

1. PubChem. "Somatropin". https://pubchem.ncbi.nlm.nih.gov/sub... (accessed September 17, 2018).
2. DrugBank. "Somatotropin - DrugBank". http://www.drugbank.ca/drugs/DB00052 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology